15:27 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

FDA approves Pfizer Nivestym, second Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The July 20 approval followed July 18...
22:22 , Jul 20, 2018 |  BC Extra  |  Company News

FDA approves Pfizer's Neupogen biosimilar

FDA approved Nivestym filgrastim-aafi from Pfizer Inc. (NYSE:PFE), its biosimilar version of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The approval includes all indications on Neupogen's label. The approval comes two days after FDA...
03:19 , Nov 17, 2017 |  BC Week In Review  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought...
23:16 , Nov 13, 2017 |  BC Extra  |  Company News

CAFC affirms Apotex biosimilars do not infringe Amgen patent

The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a...
20:27 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Adello's BLA for Neupogen biosimilar

FDA accepted for review a BLA from Adello Biologics LLC (Piscataway, N.J.) for its biosimilar candidate of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). Adello did not disclose the user fee action goal date....
21:17 , Jul 31, 2017 |  BC Extra  |  Company News

Radius Health scores with Express Scripts 2018 formulary

Radius Health Inc. (NASDAQ:RDUS) gained $1.90 to $44.03 Monday after Express Scripts Holding Co. (NASDAQ:ESRX) listed Radius' osteoporosis drug Tymlos abaloparatide-SC as a preferred alternative to Forteo teriparatide from Eli Lilly and Co. (NYSE:LLY). The...
07:00 , Sep 8, 2016 |  BC Extra  |  Company News

Court: Apotex biosimilars don't infringe Amgen patent

A federal judge ruled that two biosimilars from Apotex Inc. (Toronto, Ontario) do not infringe a patent held by Amgen Inc. (NASDAQ:AMGN). Amgen sought a ruling that Apotex's biosimilar versions of neutropenia drugs Neulasta pegfilgrastim...
08:00 , Nov 10, 2014 |  BC Week In Review  |  Company News

Amgen, Novartis biosimilars news

Amgen submitted a Citizen's Petition to FDA asking the agency to require that biosimilar applications include a certification that the applicant will comply with patent resolution protocol of the Biologics Price Competition and Innovation Act...
08:00 , Nov 3, 2014 |  BC Week In Review  |  Company News

Amgen, Novartis biosimilars news

Amgen filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Novartis' Sandoz Inc. generics unit has not followed statutory requirements related to their submission of a BLA to...
02:37 , Oct 31, 2014 |  BC Extra  |  Top Story

Amgen sues Sandoz over filgrastim biosimilar BLA

In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent resolution protocol...